Global Health Risk Framework Research and Development of Medical Products: Workshop Summary (2016) / Chapter Skim
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5 Convergence of Regulatory Expectations, Review, and Approval
5 Convergence of Regulatory Expectations, Review, and Approval
Pages 55-62
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From page 55... ...
Highlights and Main Points Made by Individual Speakers and Participantsa • Harmonization of regulatory processes and regulatory science standards among global regulatory authorities is key to being able to more effectively and rapidly assess complex products and define acceptable levels of risk in global public health emergency situations. (Eichler, Hamburg)
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From page 56... ...
. Working together, Hamburg said, global regulatory authorities will be better able to meet expectations in terms of scientific review, more effectively share information about advances in science and emerging technologies, and develop more flexible approaches to assessing complex products and defining acceptable levels of risk in public health emergency situations.
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From page 57... ...
Hamburg highlighted the International Coalition of Medicines Regulatory Authorities (ICMRA) as an activity geared toward enhancing global regulatory convergence and capacity.1 This is an executive-level coalition (comprising heads of medicine regulatory authorities)
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From page 58... ...
Other content areas include agreement on outlines of study protocols; development of bridging authorizations; flexible regulatory tools to give legal certainty to manufacturers to deploy products in countries of need; and building clinical trial infrastructure in country. Convergence on process involves aligning how interactions with product sponsors are handled from beginning to end, and across authorities.
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From page 59... ...
Platform approaches, and associated regulatory guidance, need to be further considered and developed for application in other urgent product manufacturing scenarios. Regulatory Capacity Building in Developing Countries Mike Ward, Coordinator, Prequalification Team Essential Medicines and Health Products at WHO, emphasized the importance of capacity building for the national regulatory authorities in affected countries, and where epidemics or pandemics would be predicted to take place.
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From page 60... ...
He was hopeful that it could be done, but said that it will take time. Chua said that Singapore has been working with different regulatory authorities on ways to pool resources and share 2 Reference regulatory agencies include Australia Therapeutic Goods Administration, EMA, FDA, Health Canada, or UK Medicines and Healthcare Products Regulatory Agency.
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From page 61... ...
Ward noted that there is interest in regions of Africa on joint reviews of products. There have also been two instances thus far of parallel processes, where the WHO prequalification process was done in parallel with joint reviews by the East Africa community regulators.3 Ward said that AVAREF played a key role during the Ebola crisis in helping to accelerate the scientific assessment of Ebola vaccine trials by facilitating a partnership approach to assessment.
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